Antimicrobial gas-releasing ear drainage tubes

Abstract

A nitric oxide gas-releasing conduit configured for surgical implantation through a patient's tympanic membrane. The nitric oxide gas-releasing conduit comprises a gas-permeable cured resin material configured for releasably sequestering therein gas. The gas-permeable cured resin material is charged with nitric oxide gas. The nitric oxide gas-releasing conduit may be optionally coated with an antimicrobial gas-releasing composition. The gas-releasing coating composition may be configured to release nitric oxide.

1. A process for producing an antimicrobial gas-releasing conduit suitable for surgical implantation through a patient's tympanic membrane, the process comprising:
 placing into a sealable chamber, a plurality of selected conduits comprising a gas-permeable cured resin material, said gas-permeable cured resin material configured for releasably sequestering therein permeating antimicrobial gases; 
 sealing and then controllably saturating said chamber with a selected antimicrobial gas whereby the antimicrobial gas permeates into and is releasably sequestered therein the gas-permeable cured resin material; 
 controllably evacuating unsequestered antimicrobial gas from said sealed chamber and then unsealing the chamber; and 
 individually sealing each antimicrobial gas-saturated conduit within a gas-impermeable packaging. 
 
     
     
       2. A process according to  claim 1 , wherein said gas-impermeable cured resin comprises a hydrophobic resin material. 
     
     
       3. A process according to  claim 1 , wherein said gas-impermeable cured resin is selected from the group consisting of curable silicones, polyvinyl acetates, thermoplastic elastomers, acrylonitrile-butadiene-styrene copolymer rubber, polyurethanes and selected combinations thereof. 
     
     
       4. A process according to  claim 1 , wherein the antimicrobial gas is nitric oxide. 
     
     
       5. The process according to  claim 1 , wherein said gas-releasing conduit is a tympanostomy tube. 
     
     
       6. The process according to  claim 1 , wherein said gas-releasing conduit is a myringotomy tube. 
     
     
       7. The process according to  claim 1 , wherein said gas-permeable cured resin material sequestering therein a permeating antimicrobial gas, is coated with an antimicrobial gas-releasing composition prior to sealing said antimicrobial gas-saturated conduit within a gas-impermeable packaging. 
     
     
       8. The process according to  claim 7 , wherein said antimicrobial gas-releasing composition is configured to release nitric oxide gas. 
     
     
       9. The process according to  claim 7 , wherein said antimicrobial gas-releasing composition is selected from the group consisting of nitric oxide gas-releasing intramolecular salts, S-nitrosothiols, compounds provided with N 2 O 2   −  functional groups, and combinations thereof. 
     
     
       10. A process for producing a nitric oxide gas-releasing conduit suitable for surgical implantation through a patient's tympanic membrane, the process comprising:
 commingling and intermixing a nitric-acid-saturated nitric-acid-chelating compound with a polymeric resin material capable of forming a gas-permeable cured resin; 
 producing and curing a plurality of nitric oxide gas-releasing conduits from said polymeric resin material intermixed with said nitric-acid-saturated nitric-acid-chelating compound; and 
 individually packaging and sealing said plurality of nitric oxide gas-releasing conduits into gas-impermeable containers. 
 
     
     
       11. A process according to  claim 10 , wherein the nitric-acid chelating compound is selected from the group comprising sodium nitrite, nitrosothiols, dipyridoxyl chelating agents, L-arginine, organic nitrates, organic nitrites, thionitrates, thionitrites, N-oxo-N-nitrosamines, N-nitrosamines, sydnonimines, 2-hydroxyimino-5-nitro-alkenamides, diazenium diolates, oxatriazolium compounds, oximes, syndomines, molsidomine and derivatives thereof, pirsidomine, furoxanes, nitrosonium salts, and combinations thereof. 
     
     
       12. A process according to  claim 10 , wherein the polymeric resin material is selected from the group consisting of curable silicones, polyvinyl acetates, thermoplastic elastomers, acrylonitrile-butadiene-styrene copolymer rubber, polyurethanes and combinations thereof. 
     
     
       13. The process according to  claim 10 , wherein said gas-permeable cured resin material sequestering therein nitric oxide gas, is coated with an antimicrobial gas-releasing composition prior to sealing said nitric oxide gas-releasing conduit within a gas-impermeable packaging. 
     
     
       14. The process according to  claim 10 , wherein said antimicrobial gas-releasing composition is configured to release nitric oxide gas. 
     
     
       15. The process according to  claim 10 , wherein said antimicrobial gas-releasing composition is selected from the group consisting of nitric oxide gas-releasing intramolecular salts, S-nitrosothiols, compounds provided with N 2 O 2   −  functional groups, and combinations thereof. 
     
     
       16. The process according to  claim 10 , wherein said conduit-is a tympanostomy tube. 
     
     
       17. The process according to  claim 10 , wherein said conduit-is a myringotomy tube.